Govt mulling guidelines for OTC medicines; move to reduce burden on doctors

The Centre is deliberating on guidelines for over-the-counter (OTC) medicines, a senior government official said on Friday. The move, pharma associations claim, will reduce the burden on doctors and increase access to medicines.

A K Pradhan, joint drug controller at the Central Drugs Standard Control Organisation, said the issue of regulations for OTC drugs had been recognised by all the stakeholders.

“This has been under constant discussions and deliberations in our meetings. Such regulations will also need to take care of advertising, labelling, and marketing of OTC drugs,”  Pradhan said at an event by PHD Chambers of Commerce and Industry and Organisation of Pharmaceutical Producers of India in Delhi.

Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance  that represents large domestic pharma companies, called for an effort to bring the guidelines for OTC drugs into effect, said.

Industry players present at the event highlighted that the OTC market offers a major business opportunity, but it needs transparent and clear regulations.

Azadar Khan, senior vice-president at Sun Pharma, said the Indian OTC market was estimated to be around $6.5 billion, making it a huge opportunity for business. But it also needs a consumer-centric approach, Khan said. “A transparent and clear regulation will put manufacturers at ease and will have a lot of clear information available at the patient’s level. The industry side is eager to have it as these regulations will clear clouds with regards to ambiguity in interpretation,” he said.

Shivam Puri, chief executive officer at Cipla Health, pointed out that OTCs are mainly considered medicinal products and therefore need more convincing in order to have consumers use them in daily lives.

“OTC products, such as ORS, have been seen as SOS medicines needed only in case of dehydration and diarrhoea, but it can be used in place of sugar-laced energy drinks as well,” Puri said. Thus, he said, the industry feels responsible marketing practices are necessary and the guidelines would help with that.